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M.P. Lebitasy
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ORAL 11 - Clinical Trials 1 (ID 100)
- Event: WCLC 2015
- Type: Oral Session
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:A.K. Nowak, F. Detterbeck
- Coordinates: 9/07/2015, 10:45 - 12:15, 702+704+706
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ORAL11.01 - Bevacizumab 15mg/kg Plus Cisplatin-Pemetrexed (CP) vs CP in Malignant Pleural Mesothelioma (MPM): IFCT-GFPC-0701 MAPS Randomized Phase 3 Trial (ID 2142)
11:07 - 11:18 | Author(s): M.P. Lebitasy
- Abstract
Background:
MPM median overall survival (OS) did not exceed 13 months with pemetrexed-platinum doublet, with virtually no surviving patients at 5 years. Vascular endothelial growth factor is a potent mitogen for MPM cells.
Methods:
In this French multicenter randomized phase 3 trial, eligible patients had unresectable, histologically proved MPM, age < 76, no prior chemo, PS 0-2, no thrombosis, nor bleeding. Randomized patients (1:1) received pem 500 mg/m2, CDDP 75 mg/m2 at D1, with (arm B) or without bevacizumab (arm A), 15 mg/kg Q21D, for 6 cycles. Arm B non-progressive patients received bevacizumab maintenance therapy until progression or toxicity. Primary endpoint was OS. 445 patients were to be randomized, and 385 events observed, to show a significant OS improvement, with 80% statistical power, 5% a-risk.
Results:
From Feb. 2008 to Jan. 2014, 448 patients were included in 73 centers. Males: 75.4%, median age: 65.7 years (range 34.7-75.9), PS 0-1: 96.7%. The IDMC recommended a second interim analysis after 85% of events. On 01-Jan-2015, the duration since last news was < 30 days in 105 out of 106 still living patients. Overall survival was significantly longer in the experimental arm (median: 18.8 months, 95%CI[15.9-22.6] vs. 16.1 months, 95%CI[14.0-17.9] for the reference arm, (adj.HR = 0.76, 95%CI[0.61; 0.94], p = 0.012). With only 46/448 non-progressive patients at the date of analysis, median PFS was 9.6 months, 95%CI[8.5-10.6] in bevacizumab arm vs. 7.5 months, 95%CI[6.8-8.1] (adj.HR = 0.62, 95%CI[0.50-0.75], p < 0.0001). G3-4 hematological toxicities did not significantly differ in the two arms (49.5% vs. 47.3%). Significantly more G3 proteinuria (0.0 vs. 3.1%), G3 hypertension (0.0 vs. 23%), G3-4 arterial thrombotic events (0.0 vs. 2.7%) were observed in bevacizumab arm. QOL and exploratory biomarkers studies will be also presented at time of the meeting.
Conclusion:
Bevacizumab addition to pemetrexed/cis-platin provides a significantly longer survival in pts with MPM, with acceptable toxicity, making this triplet a new treatment paradigm.
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ORAL 34 - Quality/Survival/Prognosis in Localized Lung Cancer (ID 153)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:B.C. Cho, R.L. Keith
- Coordinates: 9/09/2015, 16:45 - 18:15, 201+203
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ORAL34.01 - Compliance with Follow-Up Programs After Surgery for Non-Small Cell Lung Cancer in the Phase III IFCT-0302 Trial (ID 2148)
16:45 - 16:56 | Author(s): M.P. Lebitasy
- Abstract
- Presentation
Background:
In patients operated on for non-small cell lung cancer, several guidelines recommend a follow-up based on regular clinic visits and chest CT-scans. However, evidence to support these recommendations is poor, in the absence of randomized data. The IFCT-0302 trial is a randomized multicenter trial which compared 2 follow-up programs after complete resection for a clinical stage I, II, IIIA and T4 (pulmonary nodules in the same lobe) N0-2 NSCLC (TNM 6[th] edition). We present the results of compliance with the follow-up programs for the first 2 years after randomization.
Methods:
In the CXR arm, follow-up consisted of clinic visit and chest X-rays. In the CCT arm, patients underwent clinic visit, chest X-rays, thoraco-abdominal CT scan plus fiberoptic bronchoscopy (only mandatory for squamous cell and large cell carcinomas). In both arms, procedures were repeated every 6 months after randomization during the first 2 years, and yearly until 5 years, in the absence of recurrence or second primary cancer. Supplementary procedures were allowed in case of symptoms. Primary endpoint was overall survival.
Results:
Between January 2005 and November 2012, 1775 patients were randomized (CXR: 888; CCT: 887). Patient characteristics were well balanced between the two arms : males 76.3%, median age 62 years (range: 33-87), adenocarcinomas 56.7%, stage I-II 82.1%, lobectomy or bilobectomy 86,8%, pre- and/or post-operative radiotherapy 8.7%, and pre- and/or post-operative chemotherapy 45%. Surveillance was performed in 97% of patients at 6 months, in 94% at 12 months, in 90% at 18 months and in 84% at 24 months, and did not differ between the 2 arms. Intervals between randomization and visits were respected with no difference between arms (mean +/-SD in months from randomization: 5.93 +/- 0.84; 11.95 +/- 0.98; 18.05 +/- 0.99; 24.18 +/-1.30, respectively). In the 757 patients of the CXR arm, who had a follow-up visit at 6 months and no recurrence, 754 (99.6%) had a clinic visit and 730 (96.4%) a chest X-ray. In the 706 patients of the CCT arm who had a follow-up visit at 6 months and no recurrence, 702 (99.4%) had a clinic visit, 478 (67.7%) a chest X-ray, 678 (96%) a chest CT-scan, and 342 (48.4%) a bronchoscopy. Comparable compliance results were observed at 12, 18 and 24 months. In the CXR arm, supplementary thoracic CT-scans were done in 119 patients (15.7 %) at 6 months, in 96 (14.4 %) at 12 months, in 78 (13.2%) at 18 months and in 58 (11.4%) at 24 months. Other supplementary procedures were more frequent in the CCT arm than in the CXR arm, consisting mostly of brain imaging (at 6 months, in 93 (13.2%) and 39 (5.2%) patients, respectively, p<.001).
Conclusion:
Compliance with the follow-up programs was excellent in terms of timing. Chest X-ray was often omitted in the CCT arm. In the CXR arm, supplementary CT-scans that did not lead to a diagnosis of recurrence or second primary cancer were performed in 10 to 15% of patients. In the CCT arm, the most frequently performed supplementary procedure was brain imaging.
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